(a) Specifications. Each tablet contains 100, 200, or 400 milligrams (mg), or 1 gram (g) of phenylbutazone. Each bolus contains 1, 2, or 4 gram g of phenylbutazone.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter, as follows:

(1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-g boluses, in dogs and horses.

(2) No. 069043 for use of 100- or 200-mg or 1-g tablets in dogs and horses.

(3) Nos. 054771 and 061133 for use of 100-mg or 1-g tablets in dogs and horses.

(4) [Reserved]

(5) No. 000143 for use of 1-g tablets in horses.

(6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.

(c) Conditions of use—(1) Dogs—(i) Amount. 20 mg per pound of body weight daily.

(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Horses—(i) Amount. 1 to 2 g per 500 pounds of body weight daily.

(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[73 FR 8192, Feb. 13, 2008, as amended at 74 FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, Apr. 9, 2013; 78 FR 28826, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019]